Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

NCT05609812 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: VT-001-0070
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 33

Brief Summary

The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.

Conditions

Lupus Nephritis (LN)

Keywords

Systemic Lupus erythematosus (SLE); estimated glomerular filtration rate (eGFR); protenuria

Outcome Measures

Primary Outcomes (1)

• Renal Response as definedas UPCR ≤0.5 mg/mg, and eGFR ≥60 mL/min/1.73 m^2 or eGFR <60 mL/min/1.73 m^2 with no confirmed decrease from baseline of >20%

  Week 52

Secondary Outcomes (4)

• Renal Response with alternative success criteria

  Weeks 52 and 104

• Time to UPCR of≤0.5 mg/mg

  Week 52

• Renal Response at Week 104

  Week 104

• Time to Death or Renal-Related Event

  Week 104

Study Arms (2)

Atacicept Dose

EXPERIMENTAL

Atacicept Dose once weekly subcutaneous (SC) Injection

Drug: Atacicept

Placebo to match Atacicept

PLACEBO COMPARATOR

Placebo to match Atacicept once weekly subcutaneous (SC) injection

Drug: Placebo

Interventions

Atacicept DRUG

Once weekly subcutaneous (SC) injections by prefilled syringe

Also known as: VT-001

Atacicept Dose

Placebo DRUG

placebo

Placebo to match Atacicept

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female at least 18 years of age at time of signing consent
• Must have the ability to understand and sign and date a written informed consent form
• Diagnosis of SLE
• Biopsy- Proven Active LN
• Requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active LN
• Subject is willing to take oral MMF for the duration of the study

You may not qualify if:

• eGFR of ≤30 mL/min/1.73 m2.
• Sclerosis in 50% of glomeruli on renal biopsy.
• Evidence of rapidly progressive glomerulonephritis.
• Currently requiring renal dialysis or expected to require dialysis during the study.
• Serum igG \<7 g/L
• Active infection or high infectious risk

Sponsors & Collaborators

• Vera Therapeutics, Inc.: lead

Study Sites (33)

Vera Site # 0139

Huntsville, Alabama, 35805, United States

Location

Vera Site # 0138

La Jolla, California, 92037, United States

Location

Vera Site # 0127

La Palma, California, 90623, United States

Location

Vera Site # 0129

Long Beach, California, 90822, United States

Location

Vera Site # 0135

Northridge, California, 91324, United States

Location

Vera Site # 0136

Northridge, California, 91324, United States

Location

Vera Site # 0130

Santa Clarita, California, 91321, United States

Location

Vera Site # 0131

Torrance, California, 90502, United States

Location

Vera Site # 0143

New Haven, Connecticut, 06520, United States

Location

Vera Site # 0140

Gainesville, Florida, 32610, United States

Location

Vera Site # 0128

Miami, Florida, 33125, United States

Location

Vera Site # 0134

Atlanta, Georgia, 30309, United States

Location

Vera Site # 0137

Augusta, Georgia, 30912, United States

Location

Vera Site # 0144

Augusta, Georgia, 30912, United States

Location

Vera Site # 0147

Lawrenceville, Georgia, 30046, United States

Location

Vera Site # 0109

Chicago, Illinois, 60611, United States

Location

Vera Site # 0133

Las Vegas, Nevada, 89106, United States

Location

Vera Site # 0149

Summit, New Jersey, 07901, United States

Location

Vera Site # 0146

New York, New York, 10016, United States

Location

Vera Site # 0142

New York, New York, 10039, United States

Location

Vera Site # 0148

Cleveland, Ohio, 44109, United States

Location

Vera Site # 0145

Columbus, Ohio, 43210, United States

Location

Vera SIte # 0132

Jackson, Tennessee, 38305, United States

Location

Vera Site # 0125

Dallas, Texas, 75231, United States

Location

Vera Site # 0126

Dallas, Texas, 75231, United States

Location

Vera Site # 0122

El Paso, Texas, 79925, United States

Location

Vera Site # 0141

Coto Laurel, 00780, Puerto Rico

Location

Vera Site # 0349

A Coruña, 15006, Spain

Location

Vera Site # 0348

Barcelona, 08035, Spain

Location

Vera Site # 0347

Barcelona, 08036, Spain

Location

Vera Site #0351

Santander, 39008, Spain

Location

Vera Site # 0350

Seville, 41013, Spain

Location

Vera Site # 0346

Valencia, 4601, Spain

Location

Related Links

• Vera Therapeutics, Inc. Company Website

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Interventions

TACI receptor-IgG Fc fragment fusion protein

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joanne Curley

  Chief Development Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 8, 2022
• Study Start: November 2, 2022
• Primary Completion: March 15, 2026
• Study Completion (Estimated): December 15, 2028
• Last Updated: May 23, 2025

Record last verified: 2024-10

Locations

US (26); ES (6); PR (1)